Effects of Post-Operative Sedation for Endovascular Thrombectomy
Effects of Post-operative Sedation on Clinical Outcomes in Patients Receiving Endovascular Thrombectomy for Acute Ischemic Stroke
RenJi Hospital
1,286 participants
Nov 24, 2021
INTERVENTIONAL
Conditions
Summary
Studies from our lab indicated that long-term sedation is protective in mice with midbrain infarct. To assess whether post-operative sedation has protective effects on clinical outcomes in patients with ischemic stroke undergoing endovascular thrombectomy (ET), a multi-center, randomized clinical trial will be carried out (POSET study). In POSET study, patients receiving ET for acute ischemic stroke under general anesthesia will be randomly assigned to the control group (Con group) and the post-operative sedation group (POS group). Patients in the Con group will be recovered and extubated immediately after the surgery, whereas those in the POS group will be sedated with propofol and dexmedetomidine for another 6hrs before extubation. The primary endpoint is the score on the modified Rankin Scale assessed at 90±7 days after randomization. The hypothesis is that patients in the POS group will have improved clinical outcome in 3 months after surgery.
Eligibility
Inclusion Criteria6
- are between 18 and 85 years old
- have a clinical diagnosis of AIS due to anterior circulation large artery occlusion (including internal carotid artery or/and middle cerebral artery)
- with a score on the National Institute of Health Stroke Scale (NIHSS) ≥10 before surgery
- with a modified Rankin scale (mRS) \<3 before stroke
- have endovascular thrombectomy under GA and are confirmed to achieve successful reperfusion (mTICI 2b-3) by digital subtraction angiography (DSA) exam at the end of the operation.
- Informed consent by the patient him-/herself or his/her legal representative
Exclusion Criteria10
- previous intracranial hemorrhage within 6 weeks
- vascular stents implantation in the responsible blood vessel
- Glasgow score ≤8 points before surgery
- known allergy to heparin, aspirin, clopidogrel, rapamycin, lactic acid polymer, stainless steel, and allergy or contraindication to contrast agent
- contraindication to dexmedetomidine
- known hemoglobin less than 70g/L, platelet count less than 50×109L, international normalized ratio (INR) greater than 1.5, or other uncorrectable bleeding issues
- severe liver or kidney dysfunction, i.e. ALT or AST \>3 times the upper limit of normal, or creatinine \>1.5 times the upper limit of normal
- are pregnant or breast feeding
- have history of mental illness
- are currently participating in another clinical trial.
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Interventions
Patients with ischemic stroke will undergo endovascular thrombectomy (ET) under general anesthesia. After the ET surgery is done, patients in POS group will be sedated for 6hrs before extubation.
Patients with ischemic stroke will undergo endovascular thrombectomy (ET) under general anesthesia. Patients in Con group will be routinely recovered and extubated after the ET surgery is done.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04517383